23 February 2018 - - Brisbane, California-based food allergy treatment developer Aimmune Therapeutics, Inc.'s (NASDAQ: AIMT) Phase 3 PALISADE efficacy trial of AR101 met the primary endpoint, as 67.2% of AR101 patients ages 4–17 tolerated at least a 600-mg dose of peanut protein in the exit food challenge, compared to 4.0% of placebo patients.
Over half (50.3%) of AR101 patients ages 4–17 tolerated a 1000-mg dose of peanut protein in the exit food challenge, compared to 2.4% of placebo patients.
PALISADE enrolled a highly allergic patient population, and enrollment was balanced for baseline disease characteristics between the two treatment arms.
Hypersensitivity reactions are an expected and common side effect of oral immunotherapy. In PALISADE patients ages 4–17, 14.5% of AR101 patients experienced systemic hypersensitivity reactions, and for 98.2% of those patients, the reactions were mild or moderate. In comparison, 3.2% of placebo patients experienced systemic hypersensitivity reactions, and for all of those patients, the reactions were mild or moderate.
AR101 is a novel, investigational oral biologic drug for use in oral immunotherapy in patients with peanut allergy. The drug, which is manufactured in accordance with current Good Manufacturing Practices, has a characterized protein profile found in peanuts, analyzed to ensure consistent major allergen content. The amount of active ingredient in each AR101 capsule is controlled to ensure minimal variability of allergen content across doses of a given strength.
Aimmune Therapeutics is developing treatments for life-threatening food allergies. The company's Characterized Oral Desensitization ImmunoTherapy (CODIT) approach is intended to achieve meaningful levels of protection by desensitizing patients with defined, precise amounts of key allergens.